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Spots Global Cancer Trial Database for Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

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Trial Identification

Brief Title: Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Official Title: A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer

Study ID: NCT01935934

Study Description

Brief Summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Description: PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES: I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks or every 6 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Los Angeles General Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

City of Hope South Pasadena, South Pasadena, California, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

Kingston Health Sciences Centre, Kingston, Ontario, Canada

London Regional Cancer Program, London, Ontario, Canada

Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada

University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

Contact Details

Name: Neesha Dhani

Affiliation: University Health Network-Princess Margaret Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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